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Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03041532
Enrollment
692
Registered
2017-02-02
Start date
2017-10-01
Completion date
2018-11-30
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Detection Rate, Colorectal Neoplasms

Keywords

retroflexion proximal, colorectal cancer screening programme, adenoma detection rate, right colon

Brief summary

Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.

Interventions

PROCEDUREProximal retroflexion

The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization

PROCEDUREFrontal view

The investigator explore twice right colon with frontal viewing

Sponsors

Hospital del Rio Hortega
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Subjects participating in the Colorectal cancer Screening program with faecal immunological test \> 100ng / ml. * Ages between 50-69 years. * Adequate preparation according to the Boston scale: in right colon (score\> 2 in this section) * Informed consent.

Exclusion criteria

* Refusal to give informed consent. * Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease * Symptomatic subjects. * Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration * Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)

Design outcomes

Primary

MeasureTime frameDescription
Proximal retroflexion improve adenoma detection rate in colorectal cancer screeningthrough study completion, an average of 1 yearDetermine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool

Secondary

MeasureTime frameDescription
Second look for right colon improve adenoma detection ratethrough study completion, an average of 1 yearDetermine if a second look: retroflexion proximal or forward view improve adenoma detection rate
Rate of retroflexion related adverse eventsthrough study completion, an average of 1 year
Rate of retroflexion proximal adverse events with a pediatric colonoscopythrough study completion, an average of 1 year
Pre-procedure factorsthrough study completion, an average of 1 yearTo analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026